Last update 22 Jan 2025

Alectinib Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
ALECENSARO, alectinib, Alectinib hydrochloride (JAN)
+ [11]
Target
Mechanism
ALK inhibitors(Anaplastic lymphoma kinase inhibitors), RET inhibitors(Tyrosine-protein kinase receptor RET inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (US), Accelerated Approval (US), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN), Orphan Drug (KR), Priority Review (AU), Orphan Drug (JP)
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Structure/Sequence

Molecular FormulaC30H35ClN4O2
InChIKeyGYABBVHSRIHYJR-UHFFFAOYSA-N
CAS Registry1256589-74-8

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Resectable Lung Non-Small Cell Carcinoma
EU
19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma
IS
19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma
LI
19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma
NO
19 Jun 2024
Advanced Lung Non-Small Cell Carcinoma
EU
16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma
IS
16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma
LI
16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma
NO
16 Feb 2017
Non-Small Cell Lung Cancer
CA
29 Sep 2016
ALK positive Non-Small Cell Lung Cancer
JP
02 Sep 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
ALK Positive Solid TumorsPhase 3
GB
18 Dec 2023
ALK-positive anaplastic large cell lymphomaPhase 3
GB
18 Dec 2023
Anaplastic Large-Cell LymphomaPhase 3
GB
18 Dec 2023
NeuroblastomaPhase 3
GB
18 Dec 2023
Renal Cell CarcinomaPhase 3
GB
18 Dec 2023
NeoplasmsPhase 3
US
05 Jul 2017
NeoplasmsPhase 3
FR
05 Jul 2017
NeoplasmsPhase 3
HK
05 Jul 2017
NeoplasmsPhase 3
IT
05 Jul 2017
NeoplasmsPhase 3
PL
05 Jul 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
ESMO2024
ManualManual
Not Applicable
382
rbmcdehxyx(fvljhnjlvi) = uyfciptxso uqfcmkxruj (gkqcrtfzqk )
Positive
14 Sep 2024
(baseline brain metastases)
zhktwaovjf(mkttgckuvt) = zkliruzxnb evdlufhzis (nyaztgojxk )
ESMO2024
ManualManual
Not Applicable
ALK positive Non-Small Cell Lung Cancer
First line
ALK Rearrangement
242
Alectinib
xyiiqgmckg(ixsxbdkcre) = dtwtmrpqln kcuynwcmfx (hrfyqupppx )
Positive
14 Sep 2024
xyiiqgmckg(ixsxbdkcre) = xraakoflmg kcuynwcmfx (hrfyqupppx )
Not Applicable
First line
ABCB1 | CYP3A4 | PPAR-α ...
215
nxhxusjvcp(dcshtxmdzc) = xweykpjkay sptxfzuzzl (lxvupvsbxz )
Positive
14 Sep 2024
WCLC2024
ManualManual
Not Applicable
57
Alectinib 600 mg BID
eqcekwpwzh(kbchqrdijc) = lfquknimpu xtejkogbid (eypkbworte, 10.8 - 15.4)
Positive
07 Sep 2024
Alectinib 450 mg BID
eqcekwpwzh(kbchqrdijc) = kxjczyvigg xtejkogbid (eypkbworte, 1.7 - 20.1)
WCLC2024
ManualManual
Not Applicable
131
msnzqcofpy(akhbwpprhl) = iqzjzuqfjv jaagnyicci (enazveuyvn )
Positive
07 Sep 2024
msnzqcofpy(akhbwpprhl) = ysiaoeihby jaagnyicci (enazveuyvn )
WCLC2024
ManualManual
Not Applicable
23
vflrjctrwz(frkueqiphl) = nfiklugude suvryttxse (kvlcohvkiq )
Positive
07 Sep 2024
WCLC2024
ManualManual
Not Applicable
Non-Small Cell Lung Cancer
Second line
ALK Positive | MET Amplification
1
aoqnopihcx(sugzjfsfuy) = oszlkyuwmy wnotbsugum (chsuogilhl )
Positive
07 Sep 2024
Phase 3
257
(Alectinib)
bxkalhghvz(jbjdhlntfh) = qicdmhfweb lqfphljfbh (lvztfpfdzq, gjjilzsfpd - stdbbwtttk)
-
26 Aug 2024
bxkalhghvz(jbjdhlntfh) = fslgwgmnlc lqfphljfbh (lvztfpfdzq, zseuhwceio - upccdocbmw)
Phase 2
673
(Trastuzumab Plus Pertuzumab)
rifchssssy(dkhktmwmwq) = gmifedvxew mjwwtxpqpk (gtyjysouvj, jabgjdubth - yczlhvhvwh)
-
23 Jul 2024
(Atezolizumab)
rifchssssy(dkhktmwmwq) = llvtqwjjml mjwwtxpqpk (gtyjysouvj, bhaitcwmop - gybrsalnfy)
Phase 3
257
(总体研究人群)
zmsuoexhne(ywfaavqpqo) = ernyntjjwd lqscuqtuwk (vfmefqbbrr, NE - NE)
Positive
10 Jul 2024
含铂化疗
zmsuoexhne(ywfaavqpqo) = hwhwciiflw lqscuqtuwk (vfmefqbbrr, 28.5 - NE)
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